Quality Assurance Internship

Key To Terms Used

quality management system (QMS) Quality management system. The written rules a company follows, plus proof that it followed them.

SOP Standard operating procedure. Steps a stranger can follow without guessing.

CAPA Corrective and preventive action. What is done after a problem, and how recurrence is stopped.

DOC CONTROL Knowing which version is current, who approved it, and who was trained on it.

PMS Post-market surveillance. Watching for problems after a product is already in use.

AUDIT TRAIL The record showing who changed what, when, and why.

Intended Role

A quality system is a promise that the company does what it wrote down, and can prove it. This role supports that proof. You will help draft and control procedures, prepare audit evidence, and research post-market signals from public sources. The emphasis is on writing procedures people can actually follow and on evidence that holds up when someone asks for it, not on prior quality system experience.

Principal Duties

– Support drafting, formatting, and revision of standard operating procedures and work instructions using the approved house template.

– Maintain document control records, including version history, effective dates, and training acknowledgment tracking.

– Prepare audit and inspection readiness materials, such as evidence indexes that map each requirement to its record.

– Research public adverse event and recall databases for comparable products, and summarize the recurring themes.

– Support post-market surveillance literature searches and maintain a sourced, dated summary of findings.

– Help maintain logs for deviations, complaints, and corrective actions, tracking each item to documented closure.

– Use approved artificial intelligence (AI) tools to draft and reformat procedure text, then verify every requirement reference against its controlling document.

Example Assignments

Assignments depend on active studies, authorized data access, and the internship timeline. Examples may include: – A drafted or revised procedure with a redline summary and a training note for affected staff

– An audit readiness evidence index mapping requirements to records, with a gap list

– A post-market surveillance summary of public complaint and recall themes for a product category

Your First Two Weeks

– Read the current procedure set and map which document governs which activity.

– Pick one outdated procedure and draft a revision with a redline and change rationale.

– Build the first slice of the audit evidence index for one area.

– Search public recall and complaint databases for one product category and log the themes.

About Hopkins MedTech

Hopkins MedTech Group LLC is a U.S. company working in medical technology and in vitro diagnostics. Its work covers clinical performance studies, protocol development and site coordination, data review and quality assurance, and regulatory support for United States and European pathways. The group is also exploring AI and digital health through an early-stage research initiative in facial and skin analysis.

Required Qualifications

– Currently pursuing, or recently completed, a degree in life sciences, biomedical engineering, public health, industrial engineering, regulatory science, or a related field, or able to show equivalent self-study or project work.

– Clear, literal written English and the ability to write instructions that a stranger can follow without guessing.

– Comfort with structured, repetitive verification work and with maintaining logs to a consistent standard.

– Organized document habits, including disciplined naming, versioning, and change tracking.

– Willingness to record a finding accurately even when it reflects a gap in current practice.

– No prior quality assurance, auditing, or professional internship experience is required.

Preferred Qualifications

Not screening criteria. Coursework, labs, personal projects, and self- study all count as evidence. – Coursework or self-study in quality management, process improvement, regulatory affairs, or technical writing

– Familiarity with concepts such as document control, corrective action, deviation, or risk management

– Any experience writing procedures, lab protocols, manuals, or training material that others had to follow

What You Will Gain

– Understand how a medical device quality system links procedures, records, training, and audits into one chain.

– Practice technical writing that is judged by whether people can follow it, not by how it reads.

– Learn how post-market signals are collected and turned into corrective action.

– Leave with procedure and audit evidence samples that demonstrate genuine documentation discipline.

Deliverables

– A drafted or revised procedure with its redline and change rationale

– An audit evidence index with an open gap list

– A sourced post-market surveillance summary with the recommended follow-up

Supervision And Evaluation

Interns report to a named project lead, meet on a set weekly cadence, and receive written feedback on each deliverable. Work is evaluated on accuracy and traceability of sources, documentation quality, responsiveness to feedback, judgment about what to escalate, and disciplined use of approved AI tools. We expect steady learning and iteration rather than polished perfection on the first day.

What We Do Not Expect

– Prior internship experience, or a name-brand employer on your CV.

– Knowing the regulations, tools, or vocabulary before you start; the terms box above is where most people begin.

– Certainty. Saying what the evidence does not support is treated as a strength, not a gap.

Application And Selection

An application is a CV plus a short note naming the track you want and one project from this document you would like to work on, and why. First-round interviews are with the project lead who would supervise the work, not with a screening panel.

Data Handling, Privacy, And Responsible AI

Interns work only with data and documents they have been explicitly authorized to access. Patient-identifiable information, study data, client- confidential files, and proprietary materials must never be uploaded to public or unapproved AI services, shared outside the project team, or stored on personal accounts or devices. AI tools may be used only

where the project lead has approved them for that task, and all AI- assisted work must be independently verified before it enters any deliverable. The intern and the project lead remain accountable for the final result.

Equal Opportunity & Educational Nature

Hopkins MedTech Group LLC provides equal internship and employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic. Internships are educational in nature; interns do not provide medical advice, make regulatory determinations, or represent the company to any health authority, client, or study site. The AI and digital health initiative described here is early-stage research, not a cleared, approved, or clinically validated product. Assignments, data access, duration, and supervision are confirmed in the final project description.